1 g, 500 mg
Trade Name
Novactam
Powder and solvent for solution for injection
Request Type
New Registration
Drug Type
Generic(Multisource) Drug
Approval Date
SFDA Approved Use
NOVACTAM is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta‑lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*
Intra‑Abdominal Infections caused by beta‑lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta‑lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*).
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While NOVACTAM is indicated only for the conditions listed above, infections caused by ampicillin‑susceptible organisms are also amenable to treatment with NOVACTAM due to its ampicillin content. Therefore, mixed infections caused by ampicillin‑susceptible organisms and beta‑lactamase producing organisms susceptible to NOVACTAM should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to NOVACTAM.
Skin and Skin Structure Infections caused by beta‑lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*
Intra‑Abdominal Infections caused by beta‑lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta‑lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*).
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While NOVACTAM is indicated only for the conditions listed above, infections caused by ampicillin‑susceptible organisms are also amenable to treatment with NOVACTAM due to its ampicillin content. Therefore, mixed infections caused by ampicillin‑susceptible organisms and beta‑lactamase producing organisms susceptible to NOVACTAM should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to NOVACTAM.